Clinical Study

Stem Cell Therapy for Corneal Epithelium Regeneration following Good Manufacturing and Clinical Procedures

Table 1

Preoperative data and outcomes at 12 months of 20 eyes with ocular surface failure due to limbal stem cell deficiency syndrome (LSCD) subjected to cultivated limbal epithelial transplantation (CLET).

Eye number/gender/ageLSCD
etiology/group/grade
Cell sourceOSDI
I/F
NEI-VFQ-25I/FVisual potentialBCVA
I/F
Ciliary hyperemia (0–4) I/FCentral corneal epithelial opacity
(0–4) I/F
Corneal neovessels area
(0–4) I/F
Corneal neovessels length
(0–4) I/F
Central corneal epithelial
irregularity
(0–3) I/F
SPK
(Fluor)
(0–5) I/F
PED
(0–4) I/F
Epithelial phenotype
(IVCM)
I/F
One-year final outcome
Comments

1/M/47Chemical injury/1/TAuto-77.0/39.568.8/68.84 0.05/0.0013/24/44/4 3/43/30/20/0Mixed/ConjFailure month 3
2nd CLET (number16)
2/F/71Multiple surgeries/3/SAuto-45.0/25.071.4/74.500.00001/0.000013/01/03/0 2/03/13/11/0Mixed/cornealSuccess
3/F/79Multiple surgeries/3/TAuto-28.0/20.068.8/74.400.00001/0.000011/03/23/1 2/13/14/00/0Conj/cornealSuccess
4/M/69Multiple surgeries/3/TAuto-44.0/9.487.8/89.700.00001/0.000012/03/24/2 3/22/13/02/0Conj/mixedSuccess
5/F/63Stevens Johnson/2/S Allo-65.0/50.071.6/71.610.05/0.063/12/02/22/23/13/11/0Mixed/cornealSuccess
Failure month 35
6/M/62MMP/2/SAllo-4.1/0.391.9/91.910.8/0.83/01/04/04/02/13/00/0Mixed/cornealSuccess
7/M/66Multiple surgeries/3/SAuto-47.0/67.881.2/84.200.001/0.0013/13/24/24/33/23/01/0Mixed/cornealSuccess
8/M/36Chemical injury/1/SAuto-31.0/29.180.6/80.610.25/0.62/13/12/1 4/23/12/00/0Conj/cornealSuccess
9/F/34Stevens Johnson/2/T Allo-98.0/89.540.7/57.410.05/0.23/22/11/0 1/12/14/11/0Conj/cornealSuccess
10/F/63Stevens Johnson/2/T Allo-78.0/30.052.1/76.910.5/0.83/22/04/33/12/12/11/0Conj/cornealSuccess
11/M/27Postinfectious keratitis, PKP/3/TAuto-46.0/22.769.1/72.840.001/0.001–0.4 after 2nd surgery4/14/33/12/13/22/00/0Conj/mixedSuccess
PKP + cataract (month14) + valve
12/M/52Postinfectious keratitis/3/TAuto-62.5/5.093.0/95.330.05/0.21/03/24/24/23/22/00/0Conj/mixedSuccess
Refused PKP
13/M/36Chemical injury/1/SAuto-8.3/8.379.6/74.730.2/0.51/03/12/13/23/10/00/0Conj/cornealSuccess
14/F/54Postinfectious keratitis, PKP; RD surgeries/3/TAuto-28.0/18.881.9/84.740.0001/0.001–0.01 after 2nd surgery2/14/24/33/22/14/10/0Conj/mixedSuccess
PKP + cataract (month 30)
15/M/37Congenital aniridia/3/SAllo-98.0/56.8 16.2/28.140.001/0.013/13/23/23/23/14/12/0Conj/mixedSuccess
Refused further surgeries
16/M/48Chemical injury; previous CLET (number 1)/1/TAllo-33.0/22.766.6/64.330.001/0.0013/23/34/44/42/12/20/0Conj/ConjPartial success
Refused PKP
17/M/52Chemical injury/1/TAllo-52.0/50.012.6/37.740.001/0.0013/14/43/33/33/33/30/0Conj/ConjFailure month 4
18/F/33Chemical injury, PKP, severe ocular allergy/1/TAllo-65.0/22.760.9/73.040.62/0.014/24/44/4 4/43/32/30/0Mixed/ConjFailure month 9
19/F/49Congenital aniridia/3/TAllo-47.7/63.635.3/33.120.02/0.053/02/14/1 3/23/12/00/0Mixed/cornealSuccess
20/M/53Chemical injury/1/SAuto-31.3/9.463.7/96.310.5/0.82/13/11/1 1/23/14/02/0Conj/cornealSuccess
Mean (SD)49.5 (25.8)/34.3 (23.4)64.7 (22.9)/71.5 (19.4)0.15 (0.25)/0.20 (0.31)
Median (IQR).3.0 (1.0)/1.0 (1.3)3.0 (1.3)/2.0 (1.3)3.5 (1.3)/2.0 (2.0)3.0 (2.0)/2.0 (1.3)3.0 (1.0)/1.0 (1.0)3.0 (1.3)/0.5 (1.0)0.0 (1.0)/0.0 (0.0)

Group 1: chemical injuries, Group 2: immune-based inflammatory diseases, Group 3: noninflammatory diseases; T: total, S: severe; visual potential: 1, improvement with CLET only (corneal opacity was only superficial); 2, improvement with one surgery different from corneal transplant after CLET (i.e., cataract removal); 3, improvement with subsequent corneal transplant after CLET (corneal opacity was full thickness); 4, improvement with subsequent corneal transplant plus another surgery (cataract removal unless otherwise specified) after CLET, and 0: no possibility of improvement (i.e., due to irreversible retinal pathology). Auto-, autologous; Allo-, allogeneic; BCVA, best corrected visual acuity; BCVA values 0.01, 0.001, 0.0001, and 0.00001 equivalent to counting fingers, hand motion, light perception, and no light perception, respectively; Conj, conjunctival; Fluor, fluorescein staining; IQR, interquartile range; IVCM, in vivo confocal microscopy; MP, mucous membrane pemphigoid; NEI-VFQ-25, National Eye Institute-Visual Function Questionnaire; OSDI, ocular surface disease index; SPK, superficial punctate keratitis; PED, persistent epithelial defect; PKP, penetrating keratoplasty; and SD, standard deviation.